3DCRT vs. IMRT in Early Breast Cancer

Radiation Toxicity Clinical Trial

Official title:

Postoperative Radiotherapy With Intensity-modulated Radiation Therapy (IMRT) Using Simultaneous Integrated Boost Versus 3-dimensional Conformal Radiotherapy (3D-CRT) in Early Breast Cancer: a Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02440191
• Other study ID #: KROG 15-03
• Status: Recruiting
• Phase: Phase 3
• First received: April 28, 2015
• Last updated: June 1, 2017
• Start date: May 2015
• Est. completion date: April 2018

Study information

• Verified date: June 2017
• Source: Seoul St. Mary's Hospital
• Contact: Jong Hoon Lee, MD
• Phone: 010-8607-1269
• Email: koppul[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It has been not clinically determined whether TomoDirect was dosimetrically better than 3D-CRT for Asian patients with early breast cancer. Therefore, the objective of this study was to compare dosimetric parameters of TomoDirect and 3D-CRT in early breast cancer patients of an Asian cohort.

Description:

In breast cancer patients, helical TomoTherapy is not a suitable option since the gantry continuously rotates around the patient, and this technique can deliver low dose radiation to lungs that is associated with an occurrence of radiation pneumonitis. To avoid this inefficiency of beam usage, a TomoDirect option using static gantry positions combined with simultaneous couch translation and dynamic collimator modulation has been developed. In a pilot study, TomoDirect seemed particularly well suited for postoperative irradiation in breast cancer patients. TomoDirect achieved an optimal target volume coverage and coincident adequate normal tissue sparing in a dosimetric study. Clinical studies of TomoDirect in breast cancer patients are scarce and have been assessed only in small and retrospective series. Thus, we undertook a prospective study on the technical feasibility and toxicity of TomoDirect in breast cancer patients who received postoperative radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 690
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. histologically confirmed breast cancer after breast-conserving surgery

2. pT1-2N0

3. no evidence of distant metastasis

4. no previous malignancy

5. patient age, 20 - 80 years

6. Karnofsky performance score = 70

7. adequate bone marrow, liver, and renal function (leucocytes > 4,000/mm3, hemoglobin > 10 g/dL, platelets > 100,000/mm3; serum bilirubin < 1.5 mg/dL, serum transaminase < 2.5 times the upper normal limit; serum creatinine < 1.5 mg/dL).

8. completion of scheduled chemotherapy

Exclusion Criteria:

1. carcinoma in situ of breast

2. distant metastasis

3. mastectomy

4. male

5. both breast cancer

Related Conditions & MeSH terms

• Radiation Toxicity

Intervention

Radiation:
• 3DCRT
conventional radiotherapy

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Jong Hoon Lee

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Capelle L, Warkentin H, Mackenzie M, Joseph K, Gabos Z, Pervez N, Tankel K, Chafe S, Amanie J, Ghosh S, Parliament M, Abdulkarim B. Skin-sparing helical tomotherapy vs 3D-conformal radiotherapy for adjuvant breast radiotherapy: in vivo skin dosimetry stud — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		3-year
Secondary	Toxicity	Acute toxicity within 3 months after radiotherpy and late toxicity thereafter up to 3 years will be followed up by physicians. Adverse effects of radiotherapy were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). Incidence of toxicity grade = 2 was recorded.	acute (time frame: with 3 months after radiation) and late (time frame: up to 3 years after radiation), Participants will be followed for an expected average of 3 years.